ePrep ONE® with new 21 CFR Part 11 compliant software

We are delighted to announce that the ePrep ONE – a fully automated, end-to-end sample preparation platform for chromatography – can now be implemented for compliance with 21 CFR Part 11, enabling its use in pharmaceutical applications overseen by the FDA. Our team has worked diligently to develop a software upgrade that achieves this milestone, directly responding to feedback from multiple customers.


New software update gains crucial FDA compliance


ePrep ONE’s adherence to 21 CFR Part 11 ensures it meets the highest data integrity and security standards vital for applications in regulated industries, such as pharmaceuticals, biotechnology and healthcare. It is now possible to implement stringent controls over user access, electronic records and electronic signatures, as well as assign different access privileges to personnel based on their roles within the organisation. This role-based control feature is particularly noteworthy, as it enables fine-tuned supervision over who can access what functions and data. For instance, a junior lab technician may only have permission to export workflow reports, while a lab manager may have full access to all functions, including critical workflow parameters.



The 21 CFR Part 11 package on the ePrep ONE includes all the necessary IQ and OQ documentation* for both instrument and software validation. Helen Evans-Lemmo, Instrumentation Specialist at Ego Pharmaceuticals – a multinational skincare company based in Australia – was pivotal in assisting in the design and implementation of the software, and was the first customer to benefit from the upgrade. Helen commented: “We’ve been really impressed with the ePrep ONE, as it has removed many bottlenecks in our workflows and vastly improved productivity. However, I’d asked about CFR Part 11 compliant software option since our earliest adoption of ePrep. Having CFR Part 11 software allows Ego to create of ALOCA+ workflows that are a must when working within a regulated environment. So it’s great they took my feedback on board.”


This latest innovation demonstrates our commitment to listening to our customers and making every possible effort to help them in their applications.


* IQ – installation qualification; OQ – operational qualification